ChromaDex alleges in petition that Elysium Health product is adulterated

ChromaDex has taken the somewhat unusual step of filing a citizen’s petition with FDA alleging that Basis, the dietary supplement manufactured by Elysium Health, a one time customer, is adulterated and should be removed from the market.

Elysium Health is the brainchild of MIT scientist Leonard Guarente, PhD. The brand debuted to a certain amount of fanfare more than two years ago. The company’s website features a who’s who of industry scientific and regulatory talent and advertises research partnerships with Harvard, Cambridge and Oxford universities. Elysium has been supported until recently with a robust online advertising campaign. And, until recently the company was using two ChromaDex ingredients in Basis: Niagen, a branded from of nicotinamide riboside and pTeroPure, a nature identical synthetic form of pterostilbene. The companies had a falling out about a year ago andin late 2016 ChromaDex filed a breach of contract lawsuit​​. That lawsuit is ongoing.

Different material now used, petition alleges

In the petition​​, ChromaDex states it purchased examples of Basis at several points over a period of recent months and tested the samples. The company noted a change in the course of the testing. While all of the samples met label claim in terms of nicotinamide riboside and pterostilbene content, differences in the appearance of the product as well as its specific chemical signature led ChromaDex to conclude that Elysium is now getting these compounds from another, unidentified source. In so doing, the petition claims, Elysium now has a supplement on the market that does not have the appropriate regulatory status and contains traces of a chemical never approved for food use. x

“​ChromaDex discovered, as shown in the laboratory report attached as Exhibit 1, that Elysium's new Basis product is contaminated with toluene (CAS No. 108-88-3), an industrial solvent used in such things as paint thinners, fingernail polish, lacquers, and adhesives. In addition, Elysium is now using a nicotinamide riboside chloride ingredient in its product for which no New Dietary Ingredient Notification has been filed with the FDA and which does not have GRAS status. As such, Elysium's Basis product should be found to be adulterated and the FDA should take prompt remedial action to protect public health and safety,​”​ the petition says.

Elysium issued this statement on the matter: “​The allegations made by ChromaDex about the safety of Basis are misleading and false. These are baseless allegations made by a disgruntled former supplier with which we are currently engaged in litigation.​” ​

The Elysium supplement by Elysium Health.

ChromaDex first licensed its branded form of nicotinamide riboside called Niagen in 2012 and has since obtained FDA no objection GRAS status on the ingredient. In addition, the company also filed a successful New Dietary Ingredient notification on Niagen. ChromaDex has obtained GRAS status on pTeroPure.

Not a symbolic, but a strategic move

“​The FDA is reviewing the ​petition​​ and will respond directly to the petitioner,​”​ said FDA spokeswoman Corrine Newhart. The applicable rule states the FDA Commissioner will “​rule upon each petition . . . taking into consideration (i) available agency resources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by statute.​”​

The applicable statute goes on to say that FDA will rule on the petition within 180 days and will either approve, deny or dismiss the petition or will provide what’s called a ‘tentative’ response, meaning an explanation of why the agency can’t arrive at a decision on the petition, which could be from a number of factors including the need for more information.

Though Newhart was unwilling to go further on what will happen to the petition, other than to point to the official sources, New York-based attorney Marc Ullman, of counsel with the firm Rivkin Radler, was less reticent.

“​FDA is not going to take an enforcement action based on a citizens petition. They​’​ve repeatedly said that,​”​ he said.

Ullman said though, that filing a petition could be a good strategic move even if it might not result in getting the offending product off the market in an expeditious manner. Or at all. Ullman contacted FDA in a similar public manner for his client Mitsubishi in the matter of its BioPQQ, a brain health ingredient.

“​It​’​s a vehicle which I have used with my clients to alert the trade about what​’​s going on,​”​ Ullman said.